Key considerations for hMSC product and process development through clinical cGMP manufacturing

Sponsor

Developing allogeneic hMSC (human mesenchymal stem cells) or hMSC-based therapeutic products supported by sustainable scalable manufacturing takes years of time to develop and costs millions of dollars.

Successful development and commercialization of cell-based therapeutic product and process development not only requires a focus on quality to meet regulatory and manufacturing targets, but also needs scalability to meet clinically and commercially acceptable costs.

This webinar will explore the criticality of resource allocation during product and process development for moving novel cell-based therapeutics from product development to clinical implementation. There will also be discussion of the importance of considering long-term key raw material and scale-up needs early in development to enable early integration of products and processes, saving considerable time and money later on. Finally, the benefits of embedding a system with a demonstrated path to scalability will be examined.

Attendees will learn about:

Importance of raw material selection and strategies for streamlining progression from product and process development to clinical manufacturing for hMSC-based products.
Key considerations for when and how to implement standardized, scale-up bioreactor processes with comparability of quality parameters to support both current objectives and long-term economic sustainability.
Implications of your choice of target therapeutic agent (eg. extracellular vesicles vs hMSCs) and how it can influence decisions from product development to large-scale manufacturing.
How next-generation approaches can support these choices.

Dr. Jon Rowley

Founder and CPO, RoosterBio Inc.

Jon A. Rowley, PhD, is the Founder & Chief Product Officer of RoosterBio Inc. Jon started RoosterBio in 2013 as part of his personal quest of having the biggest impact possible on the commercial translation of technologies that incorporate living cells, including cellular therapies, engineered tissues, and tomorrow’s medical devices. Jon holds a PhD from the University of Michigan in Biomedical Engineering and has authored over 35 peer reviewed manuscripts and 20 issued or pending patents related to biomaterials development, tissue engineering, and cellular therapy. Jon started his industry career at BD as a scientist and R&D manager in a Cell & Tissue Technologies group focused on applying high throughput screening technologies to cell therapy media development and tissue engineering. Jon then contributed to the clinical development of Aastrom Biosciences’ Tissue Repair Cell product, where he was Sr Manager of Process Development responsible for manufacturing process improvements and cell delivery to the patient. Jon also spent 5 years as Director of Innovation and Process Development in Lonza’s Cell Therapy CMO business, and currently resides in Walkersville, MD with his wonderful wife and their 3 awesome children.

Dr. Rita Barcia

Vice President of Research and Development, Sentien Biotech

Dr. Barcia is a passionate scientist and industry leader with over 20 year experience in life science research and biotech. She is currently the Vice President of R&D at Sentien Biotechnologies where she has taken an MSC based cell therapy product from preclinical to clinical stages in conditions characterized by dysregulated inflammation, including COVID-19. Previously, she headed the R&D at ECBIO, a European company where she developed multiple preclinical programs for mesenchymal stem cells. She holds a PhD in Biomedical Sciences from University of the West of England, UK where she gained experience in immuno-oncology and completed two postdoctoral fellowships at Harvard Medical School in ophthalmology studying the immunology of the eye and worked on improving transplantation through gene therapy. She has published extensively and serves as a reviewer of European grants for biotechs.

Dr. Joe Candiello

Senior Product Manager, RoosterBio Inc.

Dr. Joseph Candiello is a bioengineering expert with years of experience working at the nexus of biomaterials, biophysics, and organoid engineering. During 10+ years in academic research, he focused primarily on engineering a stem cell based vascularized islet organoid system for diabetes research as well as previous studies understanding the biophysical properties of developing interstitial tissues during his PhD in Bioengineering at the University of Pittsburgh. Prior to his PhD, Joe received his BSc from the Pennsylvania State University in Engineering Science and Mechanics, where he currently serves on the department's Industry & Professional Advisory Council. Dr. Candiello joined RoosterBio as a Field Application Scientist in 2017 before his current role as Senior Product Manager helping to bring new and innovative products to the market to support MSC based therapeutics.

Joseph Takacs

Field Application Scientist, RoosterBio Inc.

Joseph Takacs, M.S., currently operates as a Field Application Scientist for RoosterBio. After joining RoosterBio in late 2016, Joseph focused much of his work within the research and development team to help advance RoosterBio's analytical, product, and process developments. In early 2020, Joseph moved to a commercial facing role to help create a world where safe and effective regenerative medicines are rapidly developed and are widely available on a global scale. Joseph received his Bachelor of Arts: Biochemistry and Molecular Biology degree from Hendrix College (Conway, AR) and earned a Master of Science: Biomedical Science degree from Hood College (Frederick, MD).

Jan Nolta

Professor, Director of the Stem Cell Program and Gene Therapy Center at University of California, Davis

Jan A. Nolta, Ph.D., is the Director of the Stem Cell Program at University of California Davis School of Medicine and directs the Institute for Regenerative Cures and the new UC Davis Gene Therapy Center. She also serves as the Scientific Director of the large UC Davis Good Manufacturing Practice Facility, and as PI of the California State Umbilical Cord Blood Collection Program. The UC Davis stem cell program has a large number of basic, translational, and clinical scientists collaborating to work toward regenerative medicine-related cures for a spectrum of diseases and injuries. Dr. Nolta is helping UC Davis teams develop numerous clinical trials of gene and cell therapy, with 40+ stem cell/regenerative medicine therapies already in the clinic, and over twenty in the pipeline. A California Institute for Regenerative Medicine “Alpha Clinic” Award was recently granted to UC Davis to administer FDA-approved stem cell and regenerative medicine therapies.

A scientist with 30 years’ experience with human Hematopoietic and Mesenchymal stem cells, gene therapy, and clinical trial development, Dr. Nolta developed her passion for cellular therapy in the early 90’s by helping to develop and administer the first umbilical cord blood hematopoietic stem cell gene therapy trials for newborns with “bubble baby disease” with her mentor Donald Kohn at the University of Southern California.

Dr. Nolta has published over 200 peer-reviewed manuscripts in the stem cell field, with over 13,000 citations, and has authored 30+ book chapters. She has served on over 250 review panels for the National Institutes of Health and other grant-funding agencies, was editor of the Book "Genetic Engineering of Mesenchymal Stem Cells", and has been Editor-in-Chief for the Journal “Stem Cells” for the past seven years.

Carolyn Yeago

Associate Director at Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Tech

Carolyn Yeago, Ph.D. is a Principle Scientist and Associate Director of Research at the Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M) at Georgia Institute of Technology, and also serves as a co-Industry Liaison Officer for the National Science Foundation Engineering Research Center for Cell Manufacturing (CMaT). She brings a unique background to these roles, with significant industry experience in medical and combination devices, including early stage technology development and assessment, business development, and strategic marketing to inform new product platform acquisitions. Dr. Yeago is responsible for overseeing research and development activities supported by the MC3M, leads a team of scientists to advance the clinical use and commercial production of therapeutic cells, and helps build and integrate industry consortium members to advise impactful research and development activities.

Dr. Yeago returned to Georgia Tech after 7 years with Halyard Health and Kimberly Clark Health Care where she directed research and evaluated technologies to inform new platform strategies. She managed multiple projects and cross-functional teams spanning a variety of areas, including nanoparticle development and performance for long-lasting local anesthetic delivery, fundamental research on nerve damage and regeneration post radio-frequency ablation, and organic and inorganic growth strategies for digestive health and wound healing businesses. Dr. Yeago brings a passion for connecting related research and ensuring commercial relevance and translation.

Dr. Carolyn Yeago received her Ph.D. in Biomedical Engineering from the Georgia Institute of Technology and Emory University, her B.S. in Biomedical and Bioengineering from North Carolina State University, and her graduate research focused on hydrodynamic modulation of embryonic stem cell differentiation.

Jim Birkhead

Director, Research & Development, Vericel Corporation

James Birkhead is a Director in the Research & Development group at Vericel Corporation in Cambridge, MA. In this role, Mr. Birkhead is responsible for defining and implementing process changes in support of Vericel’s two commercial cell therapy products Epicel® (cultured epidermal autografts) skin grafts to treat life-threatening severe burns and MACI® (autologous cultured chondrocytes on porcine collagen membrane) to repair damaged knee cartilage. Mr. Birkhead has over 20 years’ experience with developing cell therapy products.

Prior to Vericel, Mr. Birkhead was a senior scientist at Reprogenesis / Curis and Pervasis developing multiple cell therapy products from academia through clinical evaluations including managing technology transfer responsibilities with CROs. At Boston Scientific, he helped develop a novel tissue repair product for clinical and device integration indications. Mr. Birkhead studied cartilage biology while at Massachusetts General Hospital (Arthritis Research Unit) and at OsteoArthritis Sciences, a start-up company investigating novel inhibitors of cartilage degradation pathways.

Mr. Birkhead received his Bachelor of Arts degree in biological science from the University of Delaware, Newark, DE.

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